AGENDA

Clinical Data Sharing and Consent
17th March 2022 (3pm EDT / 7pm GMT / 6am AEDT)

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Meeting ID: 846 5932 5567

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Meeting ID: 846 5932 5567

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Attendees:

1. Lindsay Smith
2. Dianne Nicol
3. Maili Raven-Adams
4. Heidi Rehm
5. Clara Gaff
6. Beatrice Kaiser
7. Danya Vears
8. Ariana Gonzalez
9. Swapna Roopesh
10. Juliann Savatt
11. Elena Ghanaim
12. Danielle Azzariti
13. Yann Joly
14. Yvonne Bombard

Minutes:

MRA: Setting the scope for this roadmap item, invite Heidi to speak about the project aims and decide as a group if there is way we’d like to move forward.

HR: We organize 40-60 expert panels that do either gene or variant curation, or both. Many of the member of those panels are clinical labs and collect data in the course of clinical testing. We often are asking panels memes to contribute information that goes beyond what we share in ClinVar. Information is often shared with an expectation that no one will post anything, collegial professional sharing for improving care of patients. There’s this gray line between what’s appropriate sharing and what’s not. One of the labs came to us and wanted to make sure they are abiding by standards. Asking us to set up a doc that all members of the panel sign and say we will do this, and not do that. Ecosystem that we’re trying to define. All of our members had to go through a conflict of interest declaration, and thinking about adding a few clauses that get at data sharing concerns. It was helpful to define the appropriateness of the types of data that can do in ClinVar without consent. What’s allowable in what context.

YJ: This is definitely a very relevant question. We’re on this trajectory where we end up at more clinically relevant genetic information, what is consider research vs clinical care vs quality improvement. And what has direct patient relevance. There is some kind of tool or lexicon where we can think about different scenarios and how each of these ought to be addressed.

YJ: Gray areas where you need support of this group to reflect on?

HR: When we launched MME for example, the question about consent required to go into MME (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5669800/). We add in gene name and phenotypic data, not really specific patient info. For level 1 sharing, no consent was required in a clinical setting, just part of expectations of clinical care. On the other hand, if you want to put level 2 detail in, you should get consent. On the research side, couldn’t do anything unless it was consistent with the consent. It isn’t just an expectation. As we think about the scenario I just laid out, we have a lot of research studies with patients consented, and they dictate what can and cannot be done. On the clinical side, there’s no explicit consent form for some of that research. If us sharing this information with ClinGen expert panels, is with the explicit intent to improve interpretation for our patients, that’s clinical care.

YJ: Really talking about data taken for a clinical purpose, but question is whether you can share to help other patients, or putting in a publication or repository. What about clinical consent?

HR: It get nuances, and clinicians barely have the time for basic clinical consent. I do think we should push on this. Put out a fairly straightforward template. ClinGen developed a standard 1 page consent form for a patient to say you can share my data. Still utility in just defining what is appropriate.

CG: We’ve been thinking about sharing patient files for research and clinical reanalysis, but the benefit for others is what we’re looking into. One of things we can look at is patient consent vs transparency of information and where that line sits.

HR: Have lab transparently post what they do and provide some language around it

DA: Lab stakeholders have a lot of concerns with operationalizing it, tracking with cases you had permission to share and which you didn’t. Bringing labs in would be valuable

YB: CIHR has spearheaded a short clinical consent. Was the question about the sharing from clinical sphere and then publishing, or also how research exome data can be shared. Sounded like clinical to research, and research to public

HR: Key thing we’re after is the ability to share more detailed phenotypic information, maybe phenotypic associated with a single variant or gene. Not talking about a whole vcf or bam or cram. What are restrictions on what happens with that data? The research I'm struggling with, because most research studies are for interpreting the variant also. Maybe the better thing is to ask how far can data sharing go.

YB: It maps well into the point raised earlier, about how blurry the lines are between clinical and research. We can leverage a lot more data if we can mine.

YJ: From legal standpoint, there is a distinction between the two. From ethical and scientific, its a line that should be more a spectrum.

AG: This is something I go through every day, agree this is important. Have many questions about what I can share, is this ok.

YJ: I do think we can all agree that its an interesting topic. Next step is to formalize into a working group. What I would be interested in is if we can make this a cross work stream group. Bring some laboratory folks in. Would be great to identify a lead from the science side. If anyone is quite interested in this question and want to lead from the REWS side please email us at rews-coordinator@ga4gh.org. Can start scheduling meetings. Need to have a solution that is global and applicable across countries.

Next Steps/Action Plan:

1. Identify leads from both the scientific and rews side
2. Complete the scoping questionnaire
3. Design a specific framing question